Test1235

Test1235
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS See full prescribing information for complete Boxed Warning. The effectiveness of clopidogrel bisulfate is dependent on its activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19 [see Warnings and Precautions (5.1)]. Clopidogrel bisulfate at recommended doses forms less of that metabolite and has a smaller effect on platelet function in patients who are CYP2C19 poor metabolizers. Poor metabolizers with acute coronary syndrome or undergoing percutaneous coronary intervention treated with clopidogrel bisulfate at recommended doses exhibit higher cardiovascular event rates than do patients with normal CYP2C19 function. Tests are available to identify a patient's CYP2C19 genotype; these tests can be used as an aid in determining therapeutic strategy [see Clinical Pharmacology (12.5)]. Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers

Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Test1235 FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Test1235 in adult patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Test1235 in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Test1235 FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Test1235 in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Test1235 in pediatric patients.

Contraindications

There is limited information regarding Test1235 Contraindications in the drug label.

Warnings

WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS See full prescribing information for complete Boxed Warning. The effectiveness of clopidogrel bisulfate is dependent on its activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19 [see Warnings and Precautions (5.1)]. Clopidogrel bisulfate at recommended doses forms less of that metabolite and has a smaller effect on platelet function in patients who are CYP2C19 poor metabolizers. Poor metabolizers with acute coronary syndrome or undergoing percutaneous coronary intervention treated with clopidogrel bisulfate at recommended doses exhibit higher cardiovascular event rates than do patients with normal CYP2C19 function. Tests are available to identify a patient's CYP2C19 genotype; these tests can be used as an aid in determining therapeutic strategy [see Clinical Pharmacology (12.5)]. Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers

There is limited information regarding Test1235 Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Test1235 Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Test1235 Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Test1235 Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Test1235 in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Test1235 in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Test1235 during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Test1235 in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Test1235 in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Test1235 in geriatric settings.

Gender

There is no FDA guidance on the use of Test1235 with respect to specific gender populations.

Race

There is no FDA guidance on the use of Test1235 with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Test1235 in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Test1235 in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Test1235 in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Test1235 in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Test1235 Administration in the drug label.

Monitoring

There is limited information regarding Test1235 Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Test1235 and IV administrations.

Overdosage

There is limited information regarding Test1235 overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Test1235 Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Test1235 Mechanism of Action in the drug label.

Structure

There is limited information regarding Test1235 Structure in the drug label.

Pharmacodynamics

There is limited information regarding Test1235 Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Test1235 Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Test1235 Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Test1235 Clinical Studies in the drug label.

How Supplied

There is limited information regarding Test1235 How Supplied in the drug label.

Storage

There is limited information regarding Test1235 Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Test1235 Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Test1235 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Test1235 Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Test1235 Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.